Device Problem
Material Integrity Problem (2978)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 10/01/2018 |
Event Type
Injury
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Event Description
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It was reported that shaft rupture and vessel perforation occurred.The target lesion was located in the svt.An nc emerge balloon catheter was advanced for post-dilatation of a stent.However, the shaft of the device ruptured 1-2 inches proximal to the balloon causing vessel perforation.No further patient complications were reported and the physician was able to continue treating the patient.
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Manufacturer Narrative
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Date of event: during summer, but used the first date of the month of the aware date as no specific date was provided.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 01:02 pm ct.The report number is being corrected from: 2134265-2018-64207 to: 2134265-2018-63142.
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Event Description
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It was reported that shaft rupture and vessel perforation occurred.The target lesion was located in the svt.An nc emerge balloon catheter was advanced for post-dilatation of a stent.However, the shaft of the device ruptured 1-2 inches proximal to the balloon causing vessel perforation.No further patient complications were reported and the physician was able to continue treating the patient.It was further reported that the target lesion was located in svg (saphenous vein graft) and not svt.
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Search Alerts/Recalls
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